Development of Nanoplasmid LAMP-based Peanut Allergy Immunotherapy

DESCRIPTION provided by applicant Development of Nanoplasmid LAMP based Peanut Allergy Immunotherapy An estimated million Americans are allergic to peanut which is the most common trigger of anaphylaxis resulting in over incidents and between deaths in the US each year There are no FDA approved treatments for peanut allergy In response to NIAIDandapos s commitment to address the health challenge posed by peanut allergies Immunomic Therapeutics Inc andquot ITIandquot proposes novel and innovative SBIR Phase I research to develop ARA LAMP vax by encoding the three major peanut allergens as a single lysosomal associated membrane protein andquot LAMPandquot chimera to desensitize peanut allergic patients through a Th based mechanism delivered using a recently developed Nanoplasmid with greatly enhanced gene expression and immunogenicity ARA LAMP vax is a safe short treatment course with long lasting anaphylactic protection ITI has successfully designed tested and validated multiple antigen LAMP vax DNA formulations with a therapeutic focus on treating IgE mediated allergic diseases Recently ITI completed a Phase I clinical study of JRC LAMP vax a plasmid based immunotherapy for Japanese red cedar When administered intramuscularly IM as naked DNA in saline four times biweekly no severe adverse events were reported and skin test conversion from Japanese red cedar positive to negative was observed and maintained in out of patients out through day It is hypothesized that the observed desensitization is due to re balancing of the allergic Th immunoglobulin Ig E response by inducing a Th central memory response and high titers of allergen specific IgG The use of LAMP vax in treating serious IgE mediated diseases establishes a new level of safety by eliminating the risky exposure to free allergen as required in traditional immunotherapy This Phase I research draws on ITIandapos s experience in commercializing LAMP based allergy vaccines the innovations in plasmid design executed by ITIandapos s long time collaborators at Nature Technologies that led to the breakthrough in minimal plasmid design realized in the Nanoplasmid expression vector and previous work that showed that a DNA based multivalent peanut vaccine could provide therapeutic and prophylactic benefits in peanut allergic mice Completion of the Aims herein will provide a clear rationale for commercializing the Nanoplasmid based peanut allergy vaccine ARA LAMP vax Phase I Aims are to design and synthesize peanut allergen encoding Nanoplasmids Test ARA LAMP vax formulations in a prophylactic model of peanut allergy and Evaluate therapeutic efficacy in a mouse model of peanut anaphylaxis During Phase II ITI will prepare ARA LAMP vax under current Good Manufacturing Practices cGMP and conduct biodistribution andamp toxicology studies in support of an IND filing The goal of this project is to commercialize ARA LAMP vax ITI strongly believes that this proposal supports NIAIDandapos s commitment to address the health challenge posed by food allergy and peanut induced anaphylaxis for which there is no FDA approved treatment PUBLIC HEALTH RELEVANCE Public Health Relevance Peanuts allergies affect over a million Americans and are the most common cause of anaphylaxis a potentially lethal allergic reaction Peanut allergies disproportionately affect children and are rarely outgrown A safe and effective treatment is urgently needed to desensitize individuals at risk of anaphylaxis due to peanut exposure